NAVAL POSTGRADUATE SCHOOL
MONTEREY, CALIFORNIA

THESIS
ANTHRAX VACCINE AS A COMPONENT OF THE STRATEGIC NATIONAL STOCKPILE: A DILEMMA FOR HOMELAND SECURITY by Thomas L. Rempfer December 2009 Thesis Advisor: Second Reader: Stanley Supinski Dean Lynch

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2. REPORT DATE December 2009

3. REPORT TYPE AND DATES COVERED Master’s Thesis 5. FUNDING NUMBERS

Anthrax Vaccine as a Component of the Strategic National Stockpile: A Dilemma for Homeland Security
6. AUTHOR(S) Thomas L. Rempfer 7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) Naval Postgraduate School Monterey, CA 93943-5000 9. SPONSORING /MONITORING AGENCY NAME(S) AND ADDRESS(ES) N/A 8. PERFORMING ORGANIZATION REPORT NUMBER 10. SPONSORING/MONITORING AGENCY REPORT NUMBER

11. SUPPLEMENTARY NOTES The views expressed in this thesis are those of the author and do not reflect the official policy or position of the Department of Defense or the U.S. Government. 12a. DISTRIBUTION / AVAILABILITY STATEMENT 12b. DISTRIBUTION CODE Approved for public release; distribution is unlimited A 13. ABSTRACT (maximum 200 words)

The author explains how past problems with the Defense Department anthrax vaccine currently affect Department of Homeland Security and Department of Health and Human Service policy. The departments included the BioThrax® anthrax vaccine in the Strategic National Stockpile following the 2001 anthrax letter attacks. According to the Federal Bureau of Investigation, the vaccine’s “failing” status possibly motivated the letter attacks to create demand for the vaccine. This thesis explores the Department of Defense’s troubled experience with the vaccine through four methodologies. The multiprism methodological approach of “quadrangulation” serves to “box” in past safety, efficacy, regulatory, and legal problems. A literature review demonstrates an evolving shift in critiques of the vaccine that parallels policy pronouncements. A case study tool offers a chronological review of the anthrax vaccine to evaluate causal events precipitating the anthrax letter attacks in 2001. A program evaluation includes process tracing through quantitative, qualitative, summative, and formative reviews. Finally, a gap analysis aids in explaining continued reliance on the old vaccine technology. To conclude, the thesis recommendations encourage formulation of a Presidential Study and Policy Directive process to reassess the vaccine, while suggesting alternative Department of Homeland Security policy courses of action centered on antibiotics and new technologies.
14. SUBJECT TERMS Anthrax Vaccine Adsorbed; AVA; BioThrax; Homeland Security; Strategic National Stockpile; Biodefense; Bioterrorism; Biological Warfare; Amerithrax; Anthrax Vaccine Immunization Program; AVIP; Gulf War Illness; Gulf War Syndrome; Investigational New Drug, IND; Experimental; Civilian Control of the Military, Presidential Study Directive; PSD; Presidential Policy Directive; PPD 17. SECURITY 18. SECURITY 19. SECURITY CLASSIFICATION OF CLASSIFICATION OF THIS CLASSIFICATION OF REPORT PAGE ABSTRACT Unclassified Unclassified Unclassified
NSN 7540-01-280-5500

15. NUMBER OF PAGES 285 16. PRICE CODE 20. LIMITATION OF ABSTRACT UU Standard Form 298 (Rev. 2-89)
Prescribed by ANSI Std. 239-18

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Approved for public release; distribution is unlimited

ANTHRAX VACCINE AS A COMPONENT OF THE STRATEGIC NATIONAL STOCKPILE: A DILEMMA FOR HOMELAND SECURITY

Thomas L. Rempfer Lieutenant Colonel, Arizona Air National Guard B.S., United States Air Force Academy, 1987

Submitted in partial fulfillment of the requirements for the degree of

MASTER OF ARTS IN SECURITY STUDIES (HOMELAND SECURITY AND DEFENSE) from the NAVAL POSTGRADUATE SCHOOL December 2009

Author:

Thomas L. Rempfer

Approved by:

Dr. Stanley Supinski Thesis Advisor

Dean Lynch, Esq. Second Reader

Dr. Harold Trinkunas PhD Chair, Department of National Security Affairs iii

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ABSTRACT
The author1 explains how past problems with the Defense Department anthrax vaccine currently affect Department of Homeland Security and Department of Health and Human Services policy. The departments included the BioThrax® anthrax vaccine in the Strategic National Stockpile following the 2001 anthrax letter attacks. According to the Federal Bureau of Investigation, the vaccine’s “failing” status possibly motivated the letter attacks to create demand for the vaccine. This thesis explores the Department of Defense’s troubled experience with the vaccine through four methodologies. The multiprism methodological approach of “quadrangulation” serves to “box” in past safety, efficacy, regulatory, and legal problems. A literature review demonstrates an evolving shift in critiques of the vaccine, which parallels policy pronouncements. A case study tool offers a chronological review of the anthrax vaccine to evaluate causal events precipitating the anthrax letter attacks in 2001. A program evaluation includes process tracing through quantitative, qualitative, summative, and formative reviews. Finally, a gap analysis aids in explaining continued reliance on the old vaccine technology. To conclude, the thesis recommendations encourage formulation of a Presidential Study and Policy Directive process to reassess the vaccine, while suggesting alternative Department of Homeland Security policy courses of actions centered on antibiotics and new technologies.

1 Lieutenant Colonel Thomas Rempfer is a distinguished academic and military graduate from the U.S. Air Force Academy and prepared this thesis as a graduation requirement for the Master of Arts Program with the Naval Postgraduate School’s Center for Homeland Defense and Security. He is an Air Force Command pilot, experienced in F-16s, F-117s, A-10s, and MQ-1s. His prior service included membership on the U.S. Air Force Cyberspace Task Force, as well as flight safety and operational risk management duties. LtCol Rempfer has testified twice before Congress regarding the anthrax vaccine issue. Senior White House Office and DoD officials enlisted his expertise. He may be contacted at trempfer@aol.com.

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TABLE OF CONTENTS
I. INTRODUCTION........................................................................................................1 A. PROBLEM STATEMENT AND BACKGROUND .....................................1 1. Problem Statement...............................................................................1 2. Background ..........................................................................................1 B. RESEARCH QUESTIONS .............................................................................5 1. Primary Question.................................................................................6 2. Sub-Questions.......................................................................................6 C. RESEARCH ARGUMENT.............................................................................6 1. Summary of Claims .............................................................................6 2. Warrants...............................................................................................7 3. Evidence ................................................................................................8 4. Anticipated Challenges........................................................................9 D. METHODOLOGY ........................................................................................10 1. Literature Review ..............................................................................11 2. Case Study ..........................................................................................11 3. Program Evaluation...........................................................................12 Gap Analysis.......................................................................................14 4. LITERATURE REVIEW .........................................................................................15 A. PRE-1998 ........................................................................................................15 1. Scientific Evaluations.........................................................................15 Government Reports .........................................................................17 2. B. POST-1998......................................................................................................18 1. Scientific Evaluations.........................................................................18 2. Government Reports .........................................................................22 JUDICIAL REVIEW.....................................................................................27 C. D. STRATEGIC NATIONAL STOCKPILE ...................................................28 E. SUMMARY OF THE LITERATURE REVIEW .......................................30 CASE STUDY ............................................................................................................33 A. PHASE I - DATA COLLECTION...............................................................33 B. PHASE II – ASSESSMENT..........................................................................34 1. Identify the Problem ..........................................................................34 2. Determine the Significance of the Problem .....................................35 3. Identify the Problem’s Causes and Conditions ...............................37 a. Events and Causal Factor Relationships .............................38 b. Event and Causal Factor Analysis: Timeline .....................41 C. SUMMARY OF THE CASE STUDY ..........................................................62 PROGRAM EVALUATION ....................................................................................65 A. QUANTITATIVE ANALYSIS .....................................................................65 1. Safety...................................................................................................65 2. Efficacy................................................................................................69 3. Technology..........................................................................................72 vii

II.

III.

IV.

B.

C.

D.

E. V.

QUALITATIVE ANALYSIS........................................................................79 1. Regulatory ..........................................................................................79 2. Intelligence and Threat Assessments ...............................................86 SUMMATIVE ANALYSIS ...........................................................................90 1. Doctrinal Review................................................................................91 2. Comparative Policy Review ..............................................................95 a. Background ............................................................................96 Case #1: U.S. Policy as a Baseline for Comparison ...........98 b. c. Case #2: Canada..................................................................100 d. Case #3: United Kingdom ..................................................102 e. Case #4: France ...................................................................104 Case #5: Israel .....................................................................105 f. g. Analysis:................................................................................106 h. Conclusion ............................................................................109 3. Biosecurity ........................................................................................110 FORMATIVE ANALYSIS .........................................................................113 Current State....................................................................................113 1. 2. Executive Review .............................................................................114 Judicial Review.................................................................................118 3. 4. Legislative Review............................................................................126 SUMMARY OF THE PROGRAM EVALUATION ................................131

GAP ANALYSIS......................................................................................................133 GAP EXPLANATIONS ..............................................................................133 A. 1. Social Psychology Methodology Explains the “Gap” ...................135 a. Confirmation Bias................................................................136 b. Probability Neglect...............................................................137 c. Availability Heuristic...........................................................138 d. Negativity Bias......................................................................139 e. Social Identity Theory .........................................................140 f. “Bad Apples” or “Bad Barrel”? .........................................141 g. Closing the Psychological Gap............................................143 2. Anthrax Vaccine as a Model “Blue Ocean” Strategy ...................145 a. Eliminate, Reduce, Raise, Create Grid ..............................147 b. “Benchmark” Blue Ocean Strategy Canvas......................148 3. Power, Policy and Politicization .....................................................153 a. Power.....................................................................................156 b. Policy .....................................................................................158 c. Politicization .........................................................................160 4. Multidisciplinary Approaches to Anthrax Vaccine ......................163 a. Vignettes Critical of Anthrax Vaccine ...............................163 b. Vignettes Supporting Anthrax Vaccine .............................167 CLOSING THE GAP WITH TRUST........................................................175 B. C. SUMMARY ON THE OPENING & CLOSING OF THE GAP.............178 RECOMMENDATIONS.........................................................................................181 A. FUTURE COURSES OF ACTION............................................................181 viii

VI.

1.

B. VII.

Phase III, Corrective Actions..........................................................181 a. Presidential Study Directive (PSD) ....................................182 b. Presidential Policy Directives (PPD) ..................................183 Biodefense Czar Appointment ............................................184 c. d. Biodefense Commission (BDC)...........................................185 e. Surveillance ..........................................................................187 2. Phase IV, Inform..............................................................................188 Phase V, Follow-up ..........................................................................188 3. SUMMARY RECOMMENDED RESTORATION OF TRUST.............190

CONCLUSION ........................................................................................................191 A. REVIEW OF CLAIMS, WARRANTS, AND EVIDENCE .....................192 LIMITATIONS OF THE RESEARCH.....................................................193 B. C. SIGNIFICANCE OF THE RESEARCH...................................................194

LIST OF REFERENCES ....................................................................................................195 STATUTES AND LEGISLATION ....................................................................................235 APPENDIXES ......................................................................................................................237 EARLY LICENSURE MEMORANDUMS ......................237 APPENDIX 1: APPENDIX 2: DOD REQUEST FOR PROPOSAL ..................................240 DOD LICENSING AMENDMENT ...................................241 APPENDIX 3: APPENDIX 4: “INHALATION ANTHRAX” APPLICATION ...............246 APPLICATION UPDATE TO FDA ..................................248 APPENDIX 5: APPENDIX 6: FDA REVOKE NOTICE & INSPECTIONS....................249 DOD INDEMNIFICATION DOCUMENTS ....................251 APPENDIX 7: APPENDIX 8: TESTING AND POTENCY PROBLEMS ........................253 APPENDIX 9: KARL ROVE MEMO TO DOD ........................................255 APPENDIX 10: DOD UNDERSECRETARY MEMO ................................256 APPENDIX 11: FEDERAL BUREAU OF INVESTIGATION ..................257 INITIAL DISTRIBUTION LIST .......................................................................................261

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LIST OF FIGURES
Figure 1. Figure 2. Figure 3. Figure 4. Figure 5. Events and Causal Factor Relationships Illustration .......................................38 Timeline Illustration of Causes and Events .....................................................41 Defense Secretary Cohen and the Five-Pound Bag of Sugar .........................76 Army Times Publishing Company, “Shots In The Dark”..............................134 “Benchmark” Blue Ocean Strategy Canvas for Anthrax Vaccine.................149

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LIST OF TABLES
Table 1. Table 2. Table 3. Table 4. Table 5. Dichotomies in the Literary Record.................................................................26 BTWC and Countermeasure Policies ............................................................108 Eliminate-Reduce-Raise-Create Grid for Anthrax Vaccine ..........................147 Power versus Interest Grid.............................................................................157 Policy Attractiveness versus Stakeholder Capabilities ..................................158

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LIST OF ACRONYMS AND ABBREVIATIONS
ACHRE ACIP AFBCMR AVA AVIP BDC BDS BLA BMBL BPRP BSAT BSL BTRA BTWC BW CAAF CB CBER CBMS CBRN CDC CDFAIT CF cGMP’s CIA CIDRAP CJCS CNS CPG CRS CSS DHHS DHS DND DoD DOE DOJ DOS DVA Advisory Committee on Human Radiation Experiments Advisory Committee on Immunization Practices Air Force Board for Correction of Military Records Anthrax Vaccine Adsorbed Anthrax Vaccine Immunization Program Biodefense Commission Biohazard Detection System Biologic License Amendment Biosafety in Microbiological and Biomedical Laboratories Biological Personnel Reliability Program Biological Select Agents and Toxins Biosafety level Bioterrorism Risk Assessment Biological and Toxin Weapons Convention Biological Warfare or Biological Weapons Court of Appeals for the Armed Forces Chemical and Biological Center for Biologics, Evaluation, and Research Chemical Biological Mass Spectrometer chemical, biological, radiological, and nuclear Centers for Disease Control Canadian Department of Foreign Affairs and International Trade Canadian Forces Current Good Manufacturing Practices Central Intelligence Agency Center for Infectious Disease Research and Policy Chairman of the Joint Chiefs Center for Nonproliferation Studies Compliance Policy Guidance Congressional Research Service Center for Security Studies Department of Health and Human Services (U.S.) Department of Homeland Security (U.S.) Department of National Defence (Canada) Department of Defense (U.S.) Department of Energy (U.S.) Department of Justice (U.S.) Department of State (U.S.) Department of Veterans Affairs (U.S.) xv

EBS EO EUA FAS FBI FBO FDA FDCA FEMA FR GAO HASC HR HSAC HSPD IC IDF IMA IND IOM JAMA JPOBD MBPI MDPH MEHPA MIIS MILVAX MMRS MOD MPOD NALC NAS NIH NOIR NRC NSIAD

Emergent BioSolutions Executive Order Emergency Use Authorization Federation of American Scientists Federal Bureau of Investigation Federal Budget Office Food and Drug Administration Food Drug and Cosmetics Act Federal Emergency Management Agency Final Rule Government Accountability Office (U.S.) House Armed Services Committee House Report Homeland Security Advisory Council Homeland Security Presidential Directives Intelligence Community Israeli Defense Force Israel Medical Association Investigational New Drug Institute of Medicine Journal of the American Medical Association Joint Project Office for Biological Defense Michigan Biologic Products Institute Michigan Department of Public Health Model Emergency Health Powers Act Monterey Institute of International Studies Military Vaccine Agency Metropolitan Medical Response System Ministry of Defence (United Kingdom) Medical Plans and Operations Division National Association of Letter Carriers National Academies of Science National Institutes of Health Notice of Intent to Revoke National Research Council National Security and International Affairs Division

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PHEMCE PODs POTUS PPD PR PREP PSD QnA RAC-GWVI RFP rPA RSS SAIC SASC SNS SOTUA TPER U.K. UN UNMOVIC UPMC USAF USAMRIID USAMRMC USD USMC VHA WHO WMD

Public Health Emergency Medical Countermeasures Enterprise points of dispensing President of the United States Presidential Policy Directive Proposed Rule Public Readiness and Emergency Preparedness Presidential Study Directive Question and Answer Research Advisory Committee on Gulf War Veterans’ Illnesses Request for Proposal Recombinant Protective Antigen Receiving, staging, storage Scientific Applications International Corporation Senate Armed Services Committee Strategic National Stockpile State of the Union Address Terrorism Preparedness and Emergency Response United Kingdom United Nations UN Monitoring, Verification and Inspection Commission University of Pittsburgh Medical Center United States Air Force U.S. Army Medical Research Institute for Infectious Diseases U.S. Army Medical Research and Materiel Command Undersecretary of Defense United States Marine Corps Veterans Health Administration White House Office Weapons of Mass Destruction

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EXECUTIVE SUMMARY
The Department of Homeland Security faces a vital challenge in charting fiscally practical and legally prudent policy to protect Americans. An important aspect of the Department’s duty includes the application of fundamental checks and balances with Departmental partners when selecting biodefense countermeasures in accordance with legal and regulatory standards. The following thesis project reveals a probable analysis deficit by the government when endorsing the Defense Department’s anthrax vaccine as a citizen-wide biodefense countermeasure for the Strategic National Stockpile. Synthesizing the complex history of the Department of Defense’s intimate involvement in the early development and past promotion of the vaccine requires a diligence to objectivity. The resulting intellectually independent lens enables an evaluation process where checks and balances prevail over politics to ensure a future national biodefense policy capable of withstanding scrutiny. The genesis of this thesis began in the summer of 2008 when the Federal Bureau of Investigation revealed the motive for the anthrax letter attacks of 2001. According to investigators, the “failing” status of the vaccine program preceded the attacks and served as the possible motive for the crimes. The perpetrator sought to revive confidence in the inoculation. Following the government’s revelations, thesis research efforts endeavored to incorporate varied academic means of reviewing the anthrax vaccine from a historical context. Therefore, the thesis analyzes why the Defense Department initiative was failing prior to 2001, the mechanisms behind its revival afterward, and the depth of governmental reflection on the past problems after federal legal authorities officially connected the vaccine to the letter attacker’s motive. What at face value appears as a well-intentioned attempt to protect the citizenry of the United States from a seemingly viable biological threat, and with a reputable remedy, ultimately evolves into a disquieting story about violations of the law, altered scientific assessments, and failed oversight that warrant renewed evaluation. In the case of the anthrax vaccine, a picture emerges about a vaccine invented, patented, licensed, procured, altered, and mandated for decades almost exclusively by the military for a captive audience—soldiers. Critiqued as inadequate by military scientists, the Pentagon pursued a replacement vaccine as early as 1985, to no avail. Faced with an assumed imminent threat in 1990, on the eve of the first Persian Gulf War, the military accelerated and

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altered the vaccine’s manufacturing process, but without proper regulatory approvals. The Pentagon mandated the vaccine for deployed troops, with many later reporting unexplained illnesses. The post–Gulf War era included attempts at Food and Drug Administration oversight through notices of intent to revoke the manufacturer’s license, belated approvals of 1990s manufacturing changes, plant renovations, and generally critical reviews of the vaccine in scientific literature. Upon the expulsion of United Nations weapons inspectors from Iraq in 1997, the armed forces initiated a mandatory immunization policy for all its personnel. The renewed use of the vaccine spawned legislative inquiry and conclusions about the vaccine’s illegal mandatory use and experimental status, later confirmed by federal courts. The controversy and regulatory hurdles left the military’s use of the vaccine stalled until reinvigorated by the deaths of Americans from the anthrax letter attacks. Since the attacks, over $1 billion in allocations for the vaccine accompanied nearly $60 billion for biodefense. Now the same vaccine, recommended for replacement 25 years earlier, enjoys sole source procurement status and product liability protection, despite a dubious regulatory history. The circumstances behind the apparent willful blindness of government officials regarding the vaccine, and the anthrax immunization program’s controversial resuscitation, warrant review through multiple techniques. In order to accomplish this task, the following thesis modifies the concept of “methodological triangulation” to scrutinize the timeline of events from four angles. The resulting methodological “quadrangulation” begins with a literature review. Significantly, the thesis claims and arguments actually reiterate the original critical conclusions previously held by Defense Department officials about the vaccine’s inadequate status. The thesis methodologies continue with a case study, a program evaluation, and a gap analysis to highlight problematic oversight. While the violations of law and the troubling alteration of the scientific and regulatory record documented in the four methodologies serve as the premise of the thesis, other unresolved vaccine issues pertaining to Gulf War Illness, manufacturing deviations, and increases in vaccine potency warrant further analysis, particularly given the reactionary stockpiling of the vaccine for civilians. To conclude, the thesis recommends a Presidential Study and Presidential Policy Directive process to resurvey judgments by the Department of Homeland Security. This course of action ensures the due diligence and meticulous review required by commonsense and the law for current and future countermeasures in America’s biodefense toolbox.

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ACKNOWLEDGMENTS
Above all, the author’s wife, Louise, and children, Ryan, Kyle, and Skylar, deserve the utmost recognition for their patience with the academic pursuits preceding thesis publication. The author’s parents, Lonnie and Barbara Rempfer, and siblings, Bobbie Meyzen and Chris Rempfer, also deserve a debt of gratitude for motivating the values at the core of this work. Equally important is a heartfelt expression of gratefulness to the family of the late Lieutenant Colonel Russell E. Dingle—Jane, Megan, and Emma—to whom the author dedicates this work based on their husband and father’s inspirational leadership and stalwart exemplification of the U.S. Air Force core values: integrity, service, and excellence. A thank you as well to Dr. Stanley Supinski and Major Dean Lynch, Esq., U.S. Army Reserves. Their dispassionate advice in completing this thesis, as well as that of Dr. James Wirtz for his assistance with a preceding Homeland Security Affairs Journal article (Rempfer, 2009), aided in the assembly of a more objective and credible thesis product. A cadre of dedicated individuals warrants the author’s sincere collegial appreciation for assistance in gathering thesis research materials. Colleagues who helped make this thesis possible include Colonel Sammie Young, USAF Reserves, Ret.; Colonel Walter Schumm, US Army Reserves, Ret.; Colonel John Richardson, USAF Reserves, Ret.; Colonel John Michels, USAF Reserves, Ret; Major Dale Saran, USMC Reserves; Mark Zaid, Esq.; Arnold Menchel, Esq.; and Ted Doolittle, Esq. A sincere note of professional appreciation goes to the U.S. Air Force Academy for providing the educational and ethical foundations motivating this work. As well, supervisors and mentors, who graciously supported and encouraged the author’s academic efforts include Brigadier General David McGinnis, U.S. Army Guard, Ret.; Colonel John Block, USAF, Ret.; Colonel Juan Gaud, USAF Reserves; Colonel Lee Pritchard, USAF Reserves; and Colonel Gregg Davies, Arizona Air National Guard. Finally, the author extends the utmost appreciation to the professional Staff and Professors at the Naval Postgraduate School’s Center for Homeland Defense and Security for promoting organizational academic freedom and intellectual honesty.

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I.
A.

INTRODUCTION

PROBLEM STATEMENT AND BACKGROUND 1. Problem Statement

Documented problems with anthrax vaccine adsorbed (AVA, also known as BioThrax®) reveal historic regulatory and oversight gaps that affect national counterbioterrorism policy. Laws promulgated by the U.S. Congress and edicts by the President of the U.S. in the form of Homeland Security presidential directives (HSPDs) appoint the Secretary of the Department of Homeland Security (DHS) as the principal official for management of domestic bioterrorism events (President of the United States [POTUS], 2003b).2 The DHS, Department of Defense (DoD), and Department of Health and Human Services (DHHS) each possesses authority under HSPDs 8, 10, 18, and 21 to determine and review bioterrorism countermeasures based upon preparedness and response directives issued by the president (POTUS, 2003c; POTUS, 2004; POTUS, 2007a; POTUS, 2007b). The BioThrax® anthrax vaccine currently plays a central role in both biological warfare and bioterrorism defense policies. The delta between the past critical governmental reviews of the vaccine, compared to recent accelerated procurement following the anthrax letter attacks, dictates a comprehensive reevaluation. The conclusion of this reassessment process may render the current vaccine unnecessary as a complement to the Strategic National Stockpile (SNS), based upon the proven efficacy of antibiotics and pending the development of a satisfactory immunization. 2. Background

Anthrax as a disease results from bacterial infection due to toxins released by spores of Bacillus anthracis. The disease manifests itself through different routes of exposure. Skin infection, or cutaneous anthrax, leads to fatality rates of up to 20% absent antibiotics or